Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms

Completed · Not applicable

Conditions studied: Urinary Incontinence, Stress, Urinary Incontinence, Urge

In brief

This three-site randomized controlled trial compares the effectiveness and cost-effectiveness of a group-administered behavioral treatment program to no treatment. Women with stress, urgency, or mixed urinary incontinence will be recruited and screened centrally, evaluated clinically at each of three study sites, and random assigned to one of two treatment arms: 1. Group behavioral treatment or 2. No treatment. Group treatment modalities have the potential to reach a larger population of older women with urinary incontinence, not only in the traditional medical settings, but also in community settings. The investigators hypothesize that group behavioral treatment will be more effective than no treatment. The investigators hypothesize that the group treatment will be cost-effective compared to no treatment.

Key facts

Study ID

NCT02001714

Run by

Ananias Diokno

People needed

463

Starts

2013-09-01

Expected to finish

2016-12-01

Last updated by the study team

2017-10-19

Who can join

Age: 55 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Aged 55 years or older
• Ability to understand, read and write English
• Stress, urgency, or mixed urgency and stress urinary incontinence (UI) (by self report)
• On the International Consultation on Incontinence Modular Questionnaire - Short Form (ICIQ UI-SF), frequency of leakage at least a 1 ("about once a week or less often") on item #1 and volume of urine loss at least a 2 ("a small amount") on item #2.
• Symptoms of three months duration or longer (on history)
• Passing score (i.e., categorized as "probably not demented") on the MiniCog Test
• Timed "Up and Go" Test (TUG) score of 20 seconds or less
• Willing to undergo vaginal/pelvic examination
• Signed informed consent form

You may not qualify if…

• History of renal, bladder, uterine, ovarian, urethral, anal or rectal cancer, radiation therapy to the pelvis for any cancer/malignancy, or any active cancer/malignancy (except skin cancer)
• Non-ambulatory (participant confined to bed or wheelchair)
• Persistent pelvic pain (defined as daily pelvic pain > 3 months)
• History of neurologic or end-stage diseases (e.g. cerebral vascular accident (CVA), Parkinson's disease, multiple sclerosis, epilepsy, spinal cord tumor or trauma, spina bifida, symptomatic herniated disc)
• Previous treatment or current participation in a research study for UI, including surgery or formal behavioral treatment (pelvic floor muscle training, biofeedback, pelvic floor electrical stimulation, percutaneous tibial nerve stimulation, sacral neuromodulation, botox or other periurethral injection)
• Currently taking urinary incontinence or overactive bladder medications
• History of other urinary conditions or procedures that may affect continence status (e.g. urethral diverticula, previous augmentation cystoplasty or artificial urinary sphincter; implanted nerve stimulators for urinary symptoms)
• Participation in any drug/device research study.
• Pelvic organ prolapse protruding past the introitus (at rest or persisting after strain)
• Evidence of urinary tract infection (UTI) by urine dipstick (leukocytes +1 or greater, nitrites +1 or greater, leukocytes alone (w/o nitrites) +2 or greater, or presence of hematuria > +1). Participants may be re-screened after treatment with antibiotics or if hematuria work-up is negative.
• History of 2 or more recurrent UTI's within the past year; more than one UTI within past 6 months
• Post void residual urine volume 150 cc or more.
• Unstable medical condition (as determined by site PI)

Where it is running

• Birmingham VA Medical Cnter — Birmingham, Alabama, United States
• University of Michigan — Ann Arbor, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• University of Pennsylvania Health System, Urology — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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